What is Diabetes?
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In this section:
- What are the different types of diabetes?
- How common is diabetes?
- Who is more likely to develop type 2 diabetes?
- What health problems can people with diabetes develop?
Diabetes is a disease that occurs when your blood glucose, also called blood sugar, is too high. Blood glucose is your main source of energy and comes from the food you eat. Insulin, a hormone made by the pancreas, helps glucose from food get into your cells to be used for energy. Sometimes your body doesn’t make enough—or any—insulin or doesn’t use insulin well. Glucose then stays in your blood and doesn’t reach your cells.
Over time, having too much glucose in your blood can cause health problems. Although diabetes has no cure, you can take steps to manage your diabetes and stay healthy.
Sometimes people call diabetes “a touch of sugar” or “borderline diabetes.” These terms suggest that someone doesn’t really have diabetes or has a less serious case, but every case of diabetes is serious.
What are the different types of diabetes?
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The most common types of diabetes are type 1, type 2, and gestational diabetes.
Type 1 diabetes
If you have type 1 diabetes, your body does not make insulin. Your immune system attacks and destroys the cells in your pancreas that make insulin. Type 1 diabetes is usually diagnosed in children and young adults, although it can appear at any age. People with type 1 diabetes need to take insulin every day to stay alive.
Type 2 diabetes
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If you have type 2 diabetes, your body does not make or use insulin well. You can develop type 2 diabetes at any age, even during childhood. However, this type of diabetes occurs most often in middle-aged and older people. Type 2 is the most common type of diabetes.
Gestational diabetes
Gestational diabetes develops in some women when they are pregnant. Most of the time, this type of diabetes goes away after the baby is born. However, if you’ve had gestational diabetes, you have a greater chance of developing type 2 diabetes later in life. Sometimes diabetes diagnosed during pregnancy is actually type 2 diabetes.
Other types of diabetes
Less common types include monogenic diabetes, which is an inherited form of diabetes, and cystic fibrosis-related diabetes External link.
DESCRIPTION
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AVANDIA (rosiglitazone maleate) is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. AVANDIA improves glycemic control while reducing circulating insulin levels.
Rosiglitazone maleate is not chemically or functionally related to the sulfonylureas, the biguanides, or the alpha-glucosidase inhibitors.
Chemically, rosiglitazone maleate is (±)-5-[[4-[2-(methyl-2-pyridinylamino)ethoxy]phenyl]methyl]-2,4-thiazolidinedione, (Z)-2-butenedioate (1:1) with a molecular weight of 473.52 (357.44 free base). The molecule has a single chiral center and is present as a racemate. Due to rapid interconversion, the enantiomers are functionally indistinguishable. The structural formula of rosiglitazone maleate is:
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The molecular formula is C18H19N3O3S•C4H4O4. Rosiglitazone maleate is a white to off white solid with a melting point range of 122° to 123°C. The pKa values of rosiglitazone maleate are 6.8 and 6.1. It is readily soluble in ethanol and a buffered aqueous solution with pH of 2.3; solubility decreases with increasing pH in the physiological range.
Each pentagonal film-coated TILTAB tablet contains rosiglitazone maleate equivalent to rosiglitazone, 2 mg, 4 mg, or 8 mg, for oral administration. Inactive ingredients are: hypromellose 2910, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 3000, sodium starch glycolate, titanium dioxide, triacetin, and 1 or more of the following: synthetic red and yellow iron oxides and talc.
INDICATIONS
AVANDIA® is a thiazolidinedione antidiabetic agent indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Important Limitations of Use
- Due to its mechanism of action, AVANDIA is active only in the presence of endogenous insulin. Therefore, AVANDIA should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
- The coadministration of AVANDIA and insulin is not recommended [see WARNINGS AND PRECAUTIONS].
DOSAGE AND ADMINISTRATION
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AVANDIA may be administered at a starting dose of 4 mg either as a single daily dose or in 2 divided doses. For patients who respond inadequately following 8 to 12 weeks of treatment, as determined by reduction in fasting plasma glucose (FPG), the dose may be increased to 8 mg daily. Increases in the dose of AVANDIA should be accompanied by careful monitoring for adverse events related to fluid retention [see BOXED WARNING, WARNINGS AND PRECAUTIONS]. AVANDIA may be taken with or without food.
The total daily dose of AVANDIA should not exceed 8 mg.
Patients receiving AVANDIA in combination with other hypoglycemic agents may be at risk for hypoglycemia, and a reduction in the dose of the concomitant agent may be necessary.
Specific Patient Populations
Renal Impairment
Hepatic Impairment
Therapy with AVANDIA should not be initiated if the patient exhibits clinical evidence of active liver disease or increased serum transaminase levels (ALT >2.5X upper limit of normal at start of therapy). After initiation of AVANDIA, liver enzymes should be monitored periodically per the clinical judgment of the healthcare professional. [See WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY]
Pediatric
Data are insufficient to recommend pediatric use of AVANDIA [see Use In Specific Populations].
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